Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06751992
Phase
PHASE4
Status
Recruiting
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Conditions

  • Kidney Transplant Recipients
  • Old Age

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conversion to extended-release tacrolimus — DRUG
    Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
  • Maintenance of immediate-release tacrolimus — DRUG
    Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment

Study Details

The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).

Key Dates

Start date
Mar 17, 2026
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Envarsus XR conversion
    Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.
  • Active Comparator: Prograf maintenance
    Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.

Primary Outcome Measure

The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score) [ Time Frame: 12 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH Kidney Transplant ClinicBostonMassachusetts02114
Riella, M.D., Ph.D.
[email protected]
877-644-2860

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By research site
MGH Kidney Transplant Clinic· Boston, MA

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